SOURCE: Signature Diagnostics

October 08, 2010 10:10 ET

Signature Diagnostics to Present Company's Newest Product in Colorectal Cancer Screening at the 35th ESMO Congress in Milan

POTSDAM, GERMANY--(Marketwire - October 8, 2010) -

Signature Diagnostics / Signature Diagnostics to Present Company's Newest Product in Colorectal Cancer Screening at the 35th ESMO Congress in Milan Processed and transmitted by Thomson Reuters. The issuer is solely responsible for the content of this announcement.

* Blood-based screening test, Detector C/Plus, uses a panel of 1,802 RNA markers for increased sensitivity and specificity

Potsdam, Germany, October 8, 2010 - Signature Diagnostics announced today that Andre Rosenthal, CEO, will present the company's newest developments in colorectal cancer (CRC) screening at the Biomarker Session of the 35(th) European Society for Medical Oncology (ESMO) Congress in Milan on October 11, 2010. The abstract, entitled "An RNA Gene Signature for Screening of Colorectal Cancer from Whole Blood with High Sensitivity and a Specificity Close to that of Colonoscopy," describes Signature Diagnostics' newest product, Detector C/Plus, which was shown in a multi-center study to further increase the sensitivity and specificity of CRC screening.

Through the use of 1,802 RNA markers, Detector C/Plus has achieved even greater specificity for blood-based CRC screening. Using blood samples from a multi- center clinical study, Signature Diagnostics prospectively validated Detector C/Plus and achieved overall sensitivity S+ of 87 percent (95 percent CI: 81.8-91.4 percent). The validated specificity S- is 92.5 percent (95 percent CI: 86.6 percent-96.3 percent).

Detector C/Plus is a variant of Signature Diagnostics' Detector C product. To increase its health economic impact, Detector C/Plus has been further optimized to achieve a validated high specificity of 92.5 percent.

"The test runs on the Affymetrix GenChip platform and could be priced comparable to Detector C," André Rosenthal added. "The test's low false positive rate of 7.5 percent is close to that of colonoscopy and ensures that endoscopy resources in certain major markets will not be exhausted by large-scale use of this blood- based test."

About Signature Diagnostics AG

Signature Diagnostics AG is a molecular diagnostics company based in Potsdam, Germany, focusing on the development and commercialization of novel in- vitro diagnostic (IVD) products for early detection (screening) and prognosis of colorectal cancer. Using its state-of-the-art technologies in tissue and blood sample collection, molecular pathology, genome-wide tumor profiling technologies, data mining, and biostatistics, the company collaborates with many clinical and diagnostic partners. Signature Diagnostics sponsors and conducts large prospective, multicenter clinical trials with more than 25 primary care hospitals and several dozen colonoscopy centers in Germany to discover and validate RNA biomarkers in colorectal cancer and colorectal cancer screening.

The company plans to launch Detector C in early 2011 in its own ISO 15189 certified service lab.

About Colorectal Cancer Screening

The EU-5 and US screening population (aged 50 to 79) totals 170 million individuals. Approximately 5.1 million individuals (3 percent) have an undetected colorectal cancer. Only 360,000 CRC cases (7 percent) are currently diagnosed annually (EU-5: 220,000, USA: 140,000). Classical screening methods, including haemocult II (gFOBT) and colonoscopy, detect only 5 percent of these 360,000 CRC patients. In 4.7 million individuals affected with CRC, the asymptomatic cancer remains undetected.

In Germany, 73,000 patients are diagnosed with CRC every year. Due to the risks and inconvenience associated with CRC colonoscopy screening (bleeding events, colon perforations), patient participation is low (3 percent per year). Therefore, CRC screening using colonoscopy results in the diagnosis of only 5,400 patients each year. Furthermore, CRC screening using gFOBT is declining due to the test's inaccuracy and the difficulties associated with collecting stool samples. There is a great need for non-invasive, blood-based tests that can detect individuals with early stage CRC with high accuracy and serve as a reliable screening tool.


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Signature Diagnostics Hermannswerder 20 A Potsdam Germany

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Source: Signature Diagnostics via Thomson Reuters ONE

Contact Information

  • For questions, please contact:
    Prof. Dr. André Rosenthal, CEO
    Signature Diagnostics
    Hermannswerder 20A
    14473 Potsdam, Germany
    Tel: +49-331-2000-208
    Email Contact